ML20236K576
| ML20236K576 | |
| Person / Time | |
|---|---|
| Issue date: | 07/21/1986 |
| From: | Kerr G NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Heltemes C NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| Shared Package | |
| ML20236K265 | List:
|
| References | |
| FOIA-87-377 NUDOCS 8708070170 | |
| Download: ML20236K576 (4) | |
Text
%Q
~
\\
FH 1
Q 0
if"
%c, UNITED STATES Af W 4
Nt/ CLEAR REGOLATORY COMMISSION WASHINGTON, D. C. 2">555 Ref:
SA/J0L
%,,, j /
JUL 211996 l
l
~
MEMORANDUM F0R: Clemenes J. Heltemes, Jr., Direct,or Office for Analysis & Evaluation of
{
Operational Data j
FROM:
G. Kayre Kerr, Director Office of State Progrart,
SUBJECT:
OSP INPUT FOR ADR FOR SECCND QUARTf.R CY 1986 i
l Per your July 1,1936 recuest, enclosed is an Abnormal Occurrence Report for a medical Gisadmir.istration at Scripps Hospital, CA (enclosure 1).
Also cnclosed is an ACR submitted by Arizona (enclosure 2).
i U
e YnA I
G.Eeyne Director Office of State Programs
Enclosures:
j As stated
\\\\\\,,
8708070170 870804 FOIA PDR PDR GORDONO7-377
$/W
S l
ABNORMAL OCCURRENCE REPORT l
A, OCCURRENCE: Mo99 breakthrough and subsequent administration to four l
patients.
l 1.
Date: 5/9/85 l
l 2.
Location:
Scripps Memorial Hospital-Encinitas l
California Radioactive Materials License No. 1931-80 1
3.
Person (s)affected:
Patients' names withheld.
l B.
THE NATURE AND PROBABLE CONSEQUENCES j
1 Due to the inadvertent use of DTPA in place of sterile saline, a I
l breakthrough of Mo99 occurred in a Mo99/Tc99m generator and went unrecognized throuch administration to four patients. Doctor John l
Verba of the San Diego Veterans Admir.istration Hospital confirmea l
l the presence of Mo99 in the eiuant and estinated liver dose to three patients to be first, 130 rads, to a heart patient, and second, 260 rads to each of the two bone scan patients. Due.to the l
possible rapid clearance of the DTPA from the body, the actual doses m6y have been less. Blood results are normal, perhaps the waterial did not deposit in the vascular compartment. The whole body dose was estimated to be a few mrad. The nuclear medicine physician at the hospital reported in January 1986, "no adverse effects have been identified in any of the four patients."
C.
THECAUSE(S)0FTHEOCCURRENCE After many milkings of the Mo99/Tc99ia generator with normal eluants, it appears that DTPA, a chelating agent, was inadvertently used in place of the usual saline (the vials were almost identical). This DTPA removed a substantial amount of the Mo99 from the column. After the fact tests estimate that as much as 1.0 mci /cc may have ended up in the doses. Secondly, although Mo99 breakthrough testing was routinely perfonned, it appears that the nuclear medicine technologist observing the dose calibrator readings had come to ignore which indicator light was lit, i.e.,
millicurie or microcurie and to simply record the digital readout assuming it was microcurie. There is a practical certainty that the calibrator was indicating millicurie.
When this eluant was administered, the scan results were unuseable, but the problem was assumed to be equipment failure, which was its history. After this was shown not to be true, three more patients were injected with doses prepared from other eluants (probably using the proper saline). The same result persisted, no image, but with indications of a high energy background which proved to be from Mo99 in all four patients.
2 1
D.
CORRECTIVE ACTIONS Upon suggestion of Mo99 breakthrough, the generator was takt i out I
of service and affected patients were identified. The dose I
calibrator which had been independently checked and calibrated only 1
one month earlier was reapproved by their consultant. All l
succeeding Mo99 and aluminum breakthrough safety checks were I
confirmed by either a second nuclear medicine technician or nuclear l
medicine physician.
Finally, the hospital discontinued the use of generators and began using bulk Tc99m.
But tests for Mo99 breakthrough were continued.
1 1
The event was investigated during an onsite visit by the State.
l The licansee was cited under license condition 19 for failure to perform adequate mo99 breakthrough tests on the generator eluant.
This report was delayed because the state's medical consultant who was tsked to evaluate the patients' doses provided v3stly different (and lower) estimates than the hospital physician but did not provide further information to explain the discrepancies. Having received no reisponse froni the consultant to its inquiries, the State has accepted the hospital physician's dose estimates.
]
l 1
l l.
~
.,a 6
REPORT OF ABNORMAL OCCURRENCE l
Licensee
{
l Micro-Rei Division, Inc., Tempe, AZ.
r Date and Place i
On May 8,1985, during routine operation of a Trio-Tech Tracerflo
)
ggstem, a malfunction occurred which caused approximately 11.2 curies of Kr to be vented into the atmosphere. The facility is located in Tempe, Arizona.
j Nature and Probably Consequences During routine operation of the Trio-Tech Tracer-flo fine leak system, the unit " locked" into the first cycle of operation. The unit then began to run through the other cycles while maintaining the mechanical conditionsofthefirstcygge. This situation allowed the unwetrolled release of 11.2 curies of Kr to an unrestricted area.
Cause of Causes A thorough inspection cf the machine was mada and all mechanical systems were 5'ound to functior, properly. The faripre was due to the machine's logic board. Thfs was implied as a step-by step replacement of integrated circuits on the logic P.C, board was performed until control panel indications were normal. % init was then cycled a number of times and found to work property.
A_ctions,Taken to Prg wnt Recurrence c
Licensee -
The licensee has an exemplary maintenance program that would not have prevented this type of release.
The P.C. board logic failure can only be rectified j
by design changes by the manufacturer.
State Agency -
The Agency monitored the licensee's response to this event and confirmer! completion of the actions described above. The Agency perfonned an inspection of the circumstances associated with the event and the licensee was assessed a civil penalty in the amount of $3,000. Due to the licensee's good past history and cooperation with the Agency, the civil penalty was mitigated to $1,500, which was imposed upon and paid by the licensee.
This incident is closed for purposes of this report.